Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
Preferred Pharmaceuticals, Inc.
AZITHROMYCIN MONOHYDRATE
AZITHROMYCIN ANHYDROUS 100 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2) ]. [See Use in Specific Populations (8.4) and Clinical Studies (14.2) .] Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacteria
Azithromycin for oral suspension USP after constitution contains a cherry flavored suspension. Azithromycin for oral suspension USP is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows: Azithromycin contents per bottle NDC 300 mg (15 mL bottle) 68788-9045-1 600 mg (15 mL bottle) 68788-9046-3 [See Dosage and Administration (2) ] for constitution instructions with each bottle type. 5 mL of constituted suspension of azithromycin for oral suspension USP, 100 mg/5 mL and 200 mg/5 mL, contains 6 mg of sodium. Storage: Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.
Abbreviated New Drug Application
AZITHROMYCIN- AZITHROMYCIN MONOHYDRATE POWDER, FOR SUSPENSION PREFERRED PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AZITHROMYCIN FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN FOR ORAL SUSPENSION INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Warnings and Precautions, Hypersensitivity (5.1) 3/2017 Warnings and Precautions, Infantile Hypertrophic Pyloric Stenosis (5.3) 2/2017 INDICATIONS AND USAGE Azithromycin for oral suspension is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • • • • • • • • Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. (1.3) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.4) DOSAGE AND ADMINISTRATION • INFE C TIO N RECOMMENDED DOSE/DURATION OF THERAPY Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic bronchitis (mild to mode rate ) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days. Acute bacterial sinusitis 500 mg once daily for 3 days. Genital ulcer disease (chancroid) Non-gonococcal urethritis and cervicitis One single 1 gram dose. Gonococcal urethritis and cervicitis One single 2 gram dose. • INFE C TIO N RECOMMENDED DOSE/DURATION OF THERAPY Acute otitis media 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days Läs hela dokumentet